They also conducted follow-up interviews with eight survey respondents to provide additional insights related to survey findings. Interviewees were selected to represent a spectrum of experiences and perspectives about current and future approaches to managing prescription drug benefits.
The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in and supported by the nation's major research-based pharmaceutical companies, NPC focuses on research development, information dissemination and education on the critical issues of evidence, innovation and the value of medicines for patients.
For more information, visit www. This results in a variety of co-existing regulations depending on the regional location of the organization, the care provider, or the patient. Even beyond the U. In the U. Briefly, these organizations and their relationships include the following: Pharmaceuticals are developed and made by manufacturers, delivered to pharmacies by wholesale distributors, obtained by patients at pharmacies where there is often reduced pricing according to coverage by plan sponsors [ 6 , 7 ].
PBMs are organizations that developed to provide added value and reduced costs by specifically managing the pharmaceutical benefit on behalf of a plan sponsor. In addition to using formularies and utilization requirements to control cost and incentivize cost-effective medication use, PBMs also negotiate lower prices from manufacturers [ 8 ]. This practice is commonly known as rebating. Although ideally a cost-saving tool, rebate levels are confidential and the actual cost savings is unknown.
Under normal market conditions this would not be problematic, however, there is evidence to suggest that the most cost-effective pharmaceuticals are not being incentivized due to how PBMs sometimes place higher-priced pharmaceuticals as the preferred status on formularies and patients may spend more than they would for lower cost, equally effective alternatives [ 8 ]. Recently, PBM business practices such as rebating have begun to receive public scrutiny as the U.
Additional business practices undergoing scrutiny include exclusion lists, gag clauses, rapid fluctuation in pharmacy reimbursement rates, market consolidation and point of sale rebates [ 14 ]. In brief, exclusion lists are a way to specify non-coverage of certain medications, that is, it is a list of prescription medications that are excluded from any plan sponsor coverage. It has been noted that these exclusion lists are growing longer, in particular, for new or more expensive prescription medications [ 15 ].
Another concern with PBMs has been the fluctuation of reimbursements through the use of redirect and indirect remuneration DIR fees assessed to pharmacies, retrospectively, dependent upon pharmacy performance or upon changes in market prices [ 17 ]. Finally, as in many industries, the market consolidation of PBMs with other types of organization in the form of vertical integration challenge the intent of legal anti-trust statutes [ 7 ] pp.
Health providers often find themselves as reluctant mediators between patients and high cost pharmaceuticals. Generally, provider involvement includes prescribing, educating, dispensing, and even administration of pharmaceuticals pursuant to laws regulating the scope of practice for various types of health professions. In contrast, many community pharmacists are well versed in advocating for patient access to medications in the commercial environment of high costs [ 20 ].
It is pertinent that the experts and researchers continue work to find agreeable solutions to the problem of high costs of pharmaceuticals. To frame these discussions, an ethical framework would stand in contrast to the use of an economic or legal framework.
Although there are a number of ethical theories worthy of consideration, in comparison to other frameworks, the ethical dialog uses concepts such as avoiding harm, duty to patients, virtues, justice, or the common good. Interestingly, stakeholder organizations and their corresponding practices described above, have remained largely uncriticized in the ethical literature, with the only exception being pharmaceutical manufacturers [ 19 , 21 ]. However, PBMs have been showing signs of increased scrutiny by private nonprofit health foundations [ 8 ], the U.
The increased scrutiny directed toward PBMs has resulted from shielded business practices that may raise ethical concerns. For example, the literature has debated whether the reduced prices for some result in increased prices for others [ 13 , 19 ].
More specifically, PBMs may be causing a form of price-shifting between stakeholders, resulting in increased profits for manufacturers and PBMs, reduced revenues for pharmacies, reduced prices for some patients and plan sponsors, and increased prices for other patients and plan sponsors [ 23 ]. An ethical-oriented framework is one that is easily relatable to the case-based decisions of health care providers e. Ethical principles are used in health care to provide a moral grounding for the day to day work of providers.
The study of ethics remains an important part of education and culture for nearly all care providers charged with supporting the health of individuals in society [ 26 , 27 ]. Codes of ethics exist for clinical health professionals, and are intended to guide decision-making in the face of competing interests, social dilemmas, or conflicts encountered during the provision of care [ 28 ].
Some base a growing concern for physician burnout and failing mental health on a kind of moral crisis [ 30 ]. Further, an application of a concept previously used for combat veterans known as moral injury has been used in the context of health care and posited as resulting from providers feeling as if their work is dissonant with their own moral and ethical principles [ 31 ].
Although there is an abundance of literature in the application of ethics in health care related to the provider-patient interactions, there has been substantially less attention on how health care organizations impact providers during the delivery of care [ 32 ].
In fact, organizational ethics is considered as an adjacent field to more typical bioethics applications in health care. However, some ethical theory work has shown new approaches using contextual differences to shape discussion when a dilemma includes both clinical and organizationally ethical standpoints [ 33 ]. As the dilemma of the high costs of pharmaceuticals is situated most prominently at an organizational level, it has been rarely considered through the more common bioethical i.
Arguments to address this gap have used organizational ethics to demonstrate that stakeholder organizations can make decisions from a moral point of view in cooperation with the broader health care environment [ 21 ]. In addition, some have discussed a need for a cross-over between ethics and other fields, such as economics, to avoid economic-based solutions that inadvertently compound ethical concerns [ 19 ].
Specific to the field of pharmacy, a comprehensive review of the theory of pharmacy ethics found the existence of very little formal literature on philosophical values or frameworks specific to pharmacy [ 34 ]. Rather, this review found application of traditional medically-based bioethical concepts to pharmacy-oriented practice scenarios, as well as the application of professional codes to direct the behavior of pharmacists.
Therefore, research on pharmacy ethics presents an area ripe for investigation due to the constant balance of the clinical aspects of patient care with commercial aspects of practice, especially in the community pharmacy settings [ 34 ]. Some limited theory-based research in this area found health care organizations do shape the ethical decision-making of pharmacists [ 35 ].
For example, some research has found that professional hierarchies, closeness or distance from patient care, or daily gatekeeping i. Further, this literature has discussed that intensification of commercial pressures in the profession of pharmacy are resulting in pharmacists feeling pressure to make unethical decisions that may be in conflict with their moral values [ 36 ].
This evidence only serves to strengthen the argument of growing moral injury distress in health care providers.
With the growing concern over the moral crisis faced by providers, the authors were interested in how questionable practices by key organizations undergoing public scrutiny would stand through a framework more commonly aligned with the decision-making of providers, that of an ethical analysis. When considering potential economic and legal solutions, an ethical analysis would provide a novel and grounded framework for understanding the potential ethical considerations by providers as well as broader context for stakeholders.
Moreover, there exists a gap in the literature relating to how such organizational practices in health care, and those of PBMs in particular, might fare under ethical examination. Therefore, as a first step towards bridging this gap, this study sought to investigate the ethical nature of PBM practices using ethical decision-making models. Ethical issues in health care, including pharmacy, are commonly discussed using four core bioethical principles of beneficence, non-maleficence, autonomy and justice [ 37 , 38 ] as well as with professional codes of ethics [ 34 ].
In addition, some pharmacy specific texts have included fidelity and truthfulness as newer ethical principles with application and relevance [ 39 ].
However, work by Cooper et. These authors observed pharmacists used a range of ethical values during the reasoning process, and that various ethical approaches may have relevance to pharmacy dilemmas. Moreover, research has found that even when provided a four-stage process guideline, pharmacists displayed limited abilities in ethical reasoning [ 39 ].
Therefore, given the overall lack of literature on ethical theory in pharmacy combined with the possibility of criticism on the application of normative ethical theory i. There is some ethical theory literature which proposes the use of multiple frameworks to compare contextual differences from a clinical versus an organizational standpoint [ 28 , 33 ].
Further, this work argues complexities of health care rarely allow one model to capture value differences among all stakeholders. Thus, it would be of interest to use multiple ethical models in order to compare potential value differences encased in various ethical scenarios.
The literature suggests that pharmacists may need additional guidance for ethical decision-making in practice [ 39 ] and that there have been calls for integration of novel ethical schemas for grappling with complex and especially commercial aspects of health care [ 34 ]. As a result, the authors chose to use established decision-making models based upon a diversity of ethical theories and principles.
Philosophical decision-making models assist with debate and identification of action steps given an ethical issue. Work by Hammaker and Knadig, have summarized eight decision-making models based on the major philosophers cited by the U. Supreme Court, the U. Court of Appeals, and the state Supreme Courts since [ 40 ]. These decision-making models were appealing to use as a framework in this study because they have been used extensively in the U. They include principles from deontology, teleology, and utilitarianism as well as others.
Regarding the eight accepted decision-making models, this study chose six to use for analysis. After consideration, two models were excluded from the final analysis due to inapplicability and ambiguity of context when attempting to create a consistent assessment. In place of the two excluded decision-making models, the authors chose to examine how two professional codes of ethics might assess each of the issues.
Provider codes of ethics are also referenced in the literature as ways health care providers are taught and therefore utilize ethical values in practice [ 19 , 34 ]. In sum, because there has been a lack of ethically-based work surrounding organizations involved in the high costs of drugs and that a gap remains in ethics-based pharmacy research, this study used scrutinized PBM practices to comprehensively consider these issues within an ethical framework.
Therefore, the objective of this study was to systematically apply multiple ethical decision-making models to specific PBM practices and determine their ethical nature. In this study, several types of controversial PBM practices were chosen for evaluation. PBM practices were chosen based those receiving evaluation in U. First, this study identified if the practice was receiving scrutiny and a potential cause for increasing drug pricing [ 14 ] pp.
Second, the authors assessed if the practice could stimulate changes in the drug supply chain [ 7 ] pp. And finally, the authors predicted if this practice or related changes in the drug supply chain could present ethical concerns to providers.
If a PBM practice was able to sufficiently meet all elements for inclusion, it was evaluated using a systematic approach to determine its ethical nature. This study was limited to a maximum of five ethical scenarios to ensure a thorough analysis. The scenarios considered the market environment, including the purpose of the organization, typical goals i. The scenarios considered in this study were purposely hypothetical and therefore did not use actual cases, or details from any specific organization or company.
The models have differences in value considerations, yet all of which are considered a reputable means of determining an ethical decision with health care and the legal systems [ 40 ]. This comprehensive approach provides a framework for future work.
The chosen ethical scenarios are detailed in Table 1. This study used a systematic ethical analysis of PBM practices utilizing decision-making models [ 40 ] pp. The six decision-making models were applied to all five selected PBM practices in a detailed step-wise assessment.
The foundational ethical philosophies that comprise the six models are fully described in chapter one of the Hammaker and Knadig text [ 40 ]. These were the utility model utilitarianism , exceptions model, choices model, justice model, common good model, and virtue model. In the utility model, maximizing good and minimizing harm are the foci of this ethical determination.
The exceptions model is a unique framework to consider the ethical nature if an individual exception became the standard or norm for all. Pharmacy benefit management companies PBMs administer the prescription drug part of health insurance plans on behalf of plan sponsors such as self-insured employers, insurance companies, and health maintenance organizations HMOs. They serve as middlemen between consumers and drug companies.
PBMs negotiate drug prices and create drug formularies—lists of preferred drugs—that determine how much patients pay. PBMs have the power to drive down costs since drug companies must gain access to the PBM formularies to sell their drugs.
The precursors of PBMs include pharmacy claims processors and mail-order pharmacies. How can this be? The discrepancy derives from our country's complex system for financing and distributing pharmaceuticals. There are a number of players in this space: health insurance plans, of course -- private companies offering individual or employer-based plans, or managing benefits for government programs, such as Medicare. There are pharmacies. And there are the drug manufacturers. Coordinating among these entities, there are firms called pharmacy benefit managers , who work for insurers to administer the prescription drug portion of a health insurance plan.
As an intermediary, it's the job of the PBM to make sure covered patients have access to new drug therapies while also keeping an eye on spending for insurance companies or employers.
Over time PBMs originated in the late s , their role has evolved and their influence has grown. Today, three main companies handle the lion's share of prescription claims.
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